Utility engineer

Are you looking for a new challenge where you can apply your extensive knowledge within facilities, equipment and qualification? Do you have a strong passion for managing and validating GxP equipment/systems in a setup that support the growth of the business and ensure the patient safety? And do you want to be part of a growing Clinical Supply Packaging & Shipping (CSPS) where we secure all Novo Nordisk products for clinical trials are packed and delivered to patients all over the world? 

If so, read on to find out more about our Utility Engineer opportunity in Clinical Supply Packaging & Shipping (CSPS) at Site Måløv. 

About the position

As Utility Engineer you will be responsible for the current and future equipment/facilities, including HVAC, BMS, and FMS.

Your responsibilities will include:

Oversee upgrades, rebuilds, and problem-solving initiatives to maintain equipment in a validated state and enhance performance 

Drive LEAN processes for systematic problem-solving and execute project management activities 

Implement new equipment/facilities to support the growth in clinical trials 

As the Utility Engineer, you will work closely with various internal and external stakeholders, including project teams, regulatory bodies, vendors, and other departments. Your role will be pivotal in ensuring seamless collaboration to achieve our departmental and organizational goals. Your attention to detail and commitment to high-quality solutions will be instrumental in presenting solid validation activities, change requests, deviations, and documentation in audit situations. 

Qualifications 

To be successful in this position, you hold a Bachelor, Master or PhD in etc. Biotechnology, Design or Process. Hands-on experience within equipment and validation is a plus. Ideally you join the team with minimum 3 year’s experience and a background within GxP regulated environment in the pharmaceutical industry. But other regulated industries like aero/space, electronics, plastic production and similar is also durable. 

The following experiences will be a plus: 

Microsoft Office, Teams and Planner 

GMP-knowhow / change control / deviation handling 

Management of GxP facilities including troubleshooting, optimisation and handling of critical alarms 

Validation of GxP facilities including HVAC, BMS and FMS 

Project management with technical knowledge 

Stakeholder management cross functionally and with external suppliers 

As a professional, you are self-motivated, thrive working independently and enjoy driving projects, improvements, and initiatives across an organisation. You have a structured approach towards challenges and utilise your problem-solving skills to create a standardised way of working. Furthermore, you have a visionary and innovative outlook to drive process optimisation and digitalisation. 

Also, you are passionate about the automation and packing machinery industry with a knowledge and interest in future products and solutions. 

About the department 

The CMC Clinical Supplies Packaging & Shipping (CSPS) department is in Måløv and currently consists of 110 employees divided into six teams. Our overall goal in CMC Clinical Supplies is to ensure timely supply of our clinical studies to patients. 

We are responsible for packaging and distributing products for clinical studies and we work closely with the rest of the Clinical Supply Chain at CMC to achieve our ambitious goal of delivering high quality products on time to patients worldwide. We continuously work to optimize our processes, reduce lead time and efficient use of resources using various LEAN tools.